Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,043
- 试验地点
- 1
- 主要终点
- Late radiation-induced toxicity (grade 2 or higher)
研究概览
简要总结
In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •WHO performance status 0-
- •Invasive breast cancer or ductal carcinoma in situ (DCIS).
- •Stage I-III breast cancer or DCIS.
- •Treated with curative radiotherapy of the breast (as part of breast conserving therapy) with simultaneous integrated boost technique, with or without irradiation of the regional (including internal mammary) lymph nodes.
排除标准
- •Previous thoracic radiotherapy.
- •Previous history of malignancy, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- •Bilateral (synchrone) invasive breast cancer.
- •Treatment prior to surgery (i.e. neoadjuvant chemotherapy, neoadjuvant hormonal therapy, pre-operative radiotherapy).
- •Distant metastases at diagnosis (M1).
- •Unsufficient knowledge of Dutch language.
结局指标
主要结局
Late radiation-induced toxicity (grade 2 or higher)
时间窗: At 5 years after completion of radiation therapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
次要结局
- Overall survival(At 1,2,3,4 and 5 years after completion of radiation therapy)
- Recurrence (local)(At 1,2,3,4 and 5 years after completion of radiation therapy)
- Patient-rated symptoms(At 1,2,3,4 and 5 years after completion of radiation therapy)
- Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery(At 1,2,3,4 and 5 years after completion of radiation therapy)
- Recurrence (regional)(At 1,2,3,4 and 5 years after completion of radiation therapy)
- Recurrence (distant metastasis)(At 1,2,3,4 and 5 years after completion of radiation therapy)